NCT05643235 Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors
| NCT ID | NCT05643235 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwell Health |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2023-01-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will enroll patients initiating Bruton Tyrosine Kinase (BTK) inhibitors without history of documented arrhythmia while on therapy using the Medtronic LINQ-2 insertable cardiac monitor (ILR). The incidence of new onset atrial fibrillation (AF) and other arrhythmia will be determined. Actions taken in response to device detected arrhythmia will be recorded.
Eligibility Criteria
Inclusion Criteria: * \>18yo * Willing to sign and date consent form, * Willing to be remotely monitored * Initiating BTK inhibitor for approved condition (i.e. CLL, Waldenstrom's, etc) * Willing to have Medtronic cardiac monitor inserted to allow at minimum 24 hours continuous monitoring prior to initiating BTK inhibitor Exclusion Criteria: * Documented AF/VA in past 12 months * Cerebral Vascular Accident (CVA) or Transient Ischemic Attack (TIA) in past year * Has current implanted pulse generator, defibrillator, pacemaker, or resynchronization device * heart surgery within past 90 days * Myocardial Infarction within past 90 days * Patient is taking an anti-arrhythmic or anticoagulant * has concomitant condition that precludes safe participation in study (substance abuse, etc) * Enrollment in separate study that could confound results of this study
Contact & Investigator
Robert S Copeland-Halperin, MD
PRINCIPAL INVESTIGATOR
Northwell Health
Frequently Asked Questions
Who can join the NCT05643235 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05643235 currently recruiting?
Yes, NCT05643235 is actively recruiting participants. Contact the research team at emihelis@northwell.edu for enrollment information.
Where is the NCT05643235 trial being conducted?
This trial is being conducted at New Hyde Park, United States.
Who is sponsoring the NCT05643235 clinical trial?
NCT05643235 is sponsored by Northwell Health. The principal investigator is Robert S Copeland-Halperin, MD at Northwell Health. The trial plans to enroll 50 participants.
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